COMT on Aspirin Platelets Effects (CAPE) (CAPE)

Specific Aim I: Examine the role of genetic variation in COMT on platelet function in a blinded, randomized, placebo controlled clinical trial of daily placebo or Aspirin (81mg) for 10 ± 3 days. Platelet function will be assessed with platelet aggregometry and by fluorescence-activated cell sorting (FACS) of platelet adhesion molecules P-selectin and GPIIb/IIIa in platelets activated with arachidonic acid, thrombin, collagen, epinephrine and ADP.

Specific Aim II: Examine the effects of platelet releasates harvested at the end of each treatment arm on angiogenesis.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Drug: Placebo; Drug: Aspirin 81 mg

Detailed Description

This is a randomized double-blinded, placebo controlled study. This study is designed to detect the variation in platelet function based on COMT variation and how these platelets respond to cancerous cells.

We expect to recruit 60 healthy participants with the intention of studying 45 participants to complete the protocol.

Individuals aged 18 to 40 years will be eligible to participate in this study if they do not have history of fainting/problems related to blood draws, major chronic medical illnesses, regular or current treatment of Aspirin™.

Examine the role of genetic variation in in catechol-O-methyltransferase (COMT) on platelet function in a randomized double-blinded placebo controlled clinical trial of daily Aspirin™ (81 mg) versus placebo over 10-14 days. Platelet function will be assessed with a platelet aggregometry and by fluorescence-activated cell sorting assessment of platelet adhesion molecule GPIIIb/IIIa and p-selectin.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kathryn T Hall, PhD; Phone Number: 617 278 0938; Email: khall0@bwh.harvard.edu
• Study Contact Backup: Name: Elaine Zaharris; Phone Number: 617 278 0472; Email: ezaharris@rics.bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Kathryn Hall, PhD; Phone Number: 617-278-0938; Email: khall0@bwh.harvard.edu
      • Contact: Harvey Roweth, PhD; Email: hroweth@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy, 18-40 years

Exclusion Criteria:

• taking aspirin. Smoking, pregnancy, history of cancer of cardiovascular disease. Mental illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days	Drug: Placebo; Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days
Active Comparator: Aspirin; Aspirin (81mg) will be taken orally daily for 10-14 days.	Drug: Aspirin 81 mg; 81mg of aspirin to be taken daily for 10-14 days; Other Names: acetylsalicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
platelet aggregation	Platelets will be activated with arachidonic acid, thrombin, collagen, ADP and epinephrine	At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% expression of P-selectin on resting and activated platelets	Platelets activated with arachidonic acid, ADP, collagen and epinephrine	At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Kathryn T Hall, PhD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• Hall KT, Nelson CP, Davis RB, Buring JE, Kirsch I, Mittleman MA, Loscalzo J, Samani NJ, Ridker PM, Kaptchuk TJ, Chasman DI. Polymorphisms in catechol-O-methyltransferase modify treatment effects of aspirin on risk of cardiovascular disease. Arterioscler Thromb Vasc Biol. 2014 Sep;34(9):2160-7. doi: 10.1161/ATVBAHA.114.303845. Epub 2014 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Anticipated): January 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 2015D006250; K01HL130625 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The generation of large-scale human or non-human genome data is not an explicit plan in this proposal. However, any genomic data as it pertains to single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, or gene expression data produced from the work in this award will be made publicly available through the appropriate NIH data repositories including array express, Database of Genotypes and Phenotypes (dbGaP), Database of Short Genetic Variations (dbSNP) or Gene Expression Omnibus (GEO). We intend to share the results from this study in published manuscripts and presentations at National Meetings. Unique methodology or results developed or generated through this study will be made readily available for research purposes to qualified individuals within the scientific community. Interested researchers will be able to contact the corresponding authors of the publications for information about access to resources.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No